NCT06529887

Brief Summary

The primary objective of this work is to describe the vision, representations, and beliefs of professionals and patients regarding the role and place of the user during their care journey at the Calydial renal health facility. Methodology: a mixed qualitative and quantitative research.

  • Qualitative research: semi-structured interviews with patients and caregivers. The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers.
  • Single-center prospective quantitative study: design of two questionnaires (one for patients and one for caregivers). The objectives of the questionnaires are to:
  • Evaluate the feelings, experiences, and representations/beliefs of the patient experience by caregivers and patients.
  • Assess the understanding of the patient experience by caregivers and patients.
  • Compare the patient experience based on the following parameters: age of patients, gender, treatment duration, treatment location, treatment modality, patient autonomy.
  • Measure the gap between patient and caregiver perspectives to identify/adjust actions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1 month

First QC Date

July 1, 2024

Last Update Submit

July 29, 2024

Conditions

Keywords

patient central carepatient experienceSharing decision making

Outcome Measures

Primary Outcomes (2)

  • Understanding the experiences, knowledge, and patient experience

    Semi-structured interviews with 8 patients (all dialysis modalities) and 8 healthcare professionals to define the objectives of the quantitative survey (patient and caregiver questionnaires).

    2 years (2020 and 2021)

  • Evaluation of the care pathway experiences and factors influencing patient experience from the perspectives of patients and caregivers.

    Quantitative questionnaires for patients (all dialysis modalities) and their caregivers (nephrologists and nurses).

    2 months (february and march 2022)

Study Arms (2)

Patients

Dialysis patients (hemodialysis and peritoneal dialysis)

Professionnels

Nurses and nephrologists caring for the patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Dialysis patients and professionals working at the Calydial renal health facility

You may qualify if:

  • Patient aged 18 years or older
  • On hemodialysis for more than 3 months in one of the participating centers
  • Regardless of the etiology of renal disease

You may not qualify if:

  • Person refusing to participate in the study
  • Person unable to read or understand French well enough to complete the questionnaires
  • Inability to express consent to participate in the study
  • Cognitive disorders deemed incompatible with study participation by the investigator
  • Psychiatric disorders deemed incompatible with study participation by the investigator
  • Person protected by law
  • Patient under legal protection (safeguard of justice, curatorship, and guardianship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CALYDIAL

Irigny, 69540, France

Location

CALYDIAL

Pierre-Bénite, 69310, France

Location

CALYDIAL

Vénissieux, 69694, France

Location

CALYDIAL

Vienne, 38200, France

Location

MeSH Terms

Conditions

Patient ParticipationPatient Satisfaction

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Agnès CAILLETTE-BEAUDOIN, Dr

    Calydial

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 31, 2024

Study Start

February 7, 2022

Primary Completion

March 10, 2022

Study Completion

March 10, 2022

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations